Amytrx Therapeutic’s AMTX-100 CF3 Advances to Phase II Clinical Trial for Atopic Dermatitis
Amytrx specializes in safe and effective anti-inflammatory peptide therapies for patients with chronic inflammatory and autoimmune diseases. AMTX-100 CF3, its lead drug candidate, is known for its ability to transport across membranes, treat inflammation and modulate immune-mediated diseases instead of just inhibiting inflammation.
“We are encouraged by the biological impact on the patients of this study for their treatment with a treatment that we believe is not only effective, but that promotes adherence,” said Randy Riggs, Commercial Director at Amytrx. “We are excited about the potential of our therapeutic peptide that does not inhibit, but safely modulates inflammation to drive resolution of immune-mediated diseases.”
Working together, Amytrx and Amarex successfully completed the drug’s exploratory Phase I safety and efficacy trial in humans in 2021. Amytrx is launching the Phase II trial in adult subjects with atopic dermatitis mild to moderate using transcriptomic mapping. The study will assess the safety and efficacy of the treatment over 28 days.
Amarex designed this study, submitted the IND application for FDA approval, diligently guided Amytrx through the Phase I trial, and is poised to continue to lead the product through the FDA trials until it is approved for the market.
“We are delighted that our expert solutions and dedicated staff helped Amytrx achieve this critical milestone on time.” says dr. Kazem Kazempur, President and CEO of Amarex. “The FDA has given us the green light to proceed with this adaptive design trial moving from Phase I, illustrating our commitment to helping sponsors accelerate their development of safe and innovative treatments for patients. Amarex is honored to work with Amytrx on their revolutionary anti-inflammatory treatment project. »
Based on the safety profile of AMTX-100 CF3 in Phase I/II, Amytrx plans to approach adolescent and juvenile subjects in its Phase II. Amytrx is actively pursuing the use of AMTX-100 in other indications and is collaborating with institutions on its leukocyte-targeted cell-penetrating peptide delivery platforms to address other unmet medical needs in the areas of inflammation, autoimmune diseases and cancer.
Amytrx Therapeutics, Inc. is a clinical-stage biopharmaceutical company pioneering the first anti-inflammatory human peptide platform (AMTX-100) offering the potential for highly optimized breakthrough therapies that safely alter the course of chronic inflammation and metabolic dysfunction to prevent and treating some of the world’s most debilitating diseases. For more information, please visit www.amytrx.com.
Clinical Research Amarex, LLC (www.amarexcro.com), an NSF company, is a full-service global contract research organization (CRO), whose leadership has significant expertise in biomedical research. Their combined experience includes the design and conduct of several hundred clinical research projects in numerous therapeutic indications. Amarex provides project management services: Phase I-IV, BE/BA, PK/PD; regulatory affairs: FDA applications and meetings, applications to international health authorities, GxP compliance audits; clinical operations; adaptive study designs; statistical analysis, data management; medical supervision; safety and pharmacovigilance; and general consultation. Amarex can support your product through the approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval request. Join our growing list of customers with trusted products backed by quality, cost-effective services. For more information, visit www.amarexcro.com.
NSF (nsf.org) is an independent, global organization that facilitates the development of standards and tests and certifies products for the food, water, health sciences and consumer goods industries to minimize harmful effects on health and protect the environment. Founded in 1944, NSF is committed to protecting human health and safety worldwide. Present in 180 countries, NSF is a Pan American Health Organization and World Health Organization (WHO) Collaborating Center on Food Safety, Water Quality and Indoor Environment.
NSF’s health science services include training and education, consulting, clinical research, regulatory guidance, corporate compliance, and separately auditing, GMP and GLP analytical testing, testing ADN, certification and R&D for the pharmaceutical biotechnology, medical device and dietary supplement industries. throughout the product life cycle.
SOURCE Amytrx Therapeutics